P.F.C. 86-6883Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295217657), received between May 25, 2018 and Sep 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FLUTED ROD EXTRACTOR TIP BROKEN OFF FLUTED STEM END OF ROD EXTRACTOR BROKE INSIDE STEM. TIME ADDED ON ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380008 ↗
• MalfunctionDec 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  STEM DISENGAGED FROM HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8164910 ↗
• MalfunctionMay 25, 2018Break; Break

  IT WAS REPORTED THAT 2 115 X 12 STEM TRIALS BROKE WHILE IMPACTING, ALL PARTS RETRIEVED. IT WAS ALSO INDICATED THAT THE 2.5 X 12 MM INSERT TRIAL METAL POST BENT. NO SURGICAL DELAY. PARTS WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544124 ↗
• MalfunctionMay 25, 2018Break; Break

  IT WAS REPORTED THAT 2 115 X 12 STEM TRIALS BROKE WHILE IMPACTING, ALL PARTS RETRIEVED. IT WAS ALSO INDICATED THAT THE 2.5 X 12 MM INSERT TRIAL METAL POST BENT. NO SURGICAL DELAY. PARTS WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544110 ↗